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FDA最新指导原则:药物分析程序及方法验证指导原则
Guidance for Industry
Analytical Procedures and
Methods Validation for Drugs
and Biologics
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to . Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact (CDER) Lucinda Buhse 314-539-2134, or
(CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827-
1800.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
February 2014
CMC
Guidance for Industry
Analytical Procedures and
Methods Validation for Drugs
and Biologics
Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 220 1
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave
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